Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug Regulations and Medical Devices Regulations and are intended to:
- reduce regulatory irritants and roadblocks to innovation;
- make Canada’s science-based regulatory system more agile; and
- bring Canada’s regulatory system in line with international approaches.
As described in the Regulatory Impact Analysis Statement, the Regulations will:
- enable the use of terms and conditions (T&Cs) on the drug identification number (DIN) of any drug;
- broaden the scope of use of T&Cs on Class II, III and IV medical device licences;
- require risk management plans for certain human drugs to manage risks and uncertainties;
- expand the flexibilities for COVID-19 drugs to other public health emergency drugs, including the option of a rolling review of the submission;
- clarify expectations that a drug be fabricated, packaged/labelled, tested and stored, including during transportation, in a manner that assures its quality;
- modernize requirements for biologics by repealing outdated requirements and replacing them with those that reflect current practices;
- clarify, in regulation, the authority to consider certain information obtained outside of a drug submission to support Health Canada’s examination of that submission;
- require manufacturers to submit clinical trial data broken down by different subgroups (disaggregated data) for certain drug submissions, as submitted to the United States Food and Drug Administration or the European Medicines Agency; and
- update requirements relating to the inclusion of drug standard information on labels and for manufacturers that use a manufacturer’s standard for their drug.
The following regulatory amendments are now in force:
- public health emergency drugs (including T&Cs, rolling reviews and pre-positioning);
- assuring drug quality during manufacturing;
- information considered to support the examination of a drug submission;
- disaggregated clinical trial data for new drug submissions and supplements to new drug submissions; and
- standards.
The balance of the amendments will come into force as follows:
- Modernizing requirements for biologics – July 1, 2025;
- T&Cs for Class II, III and IV medical devices – January 1, 2026;
- T&Cs for all drugs – April 1, 2027; and
- Risk management plans – April 1, 2027.
Related guidance documents and notices that have been published thus far are:
- Guidance on the Food and Drug Regulations for public health emergency drugs
- Guidance document: Labelling of pharmaceutical drugs for human use
- Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions and Abbreviated New Drug Submissions
- New agile regulatory provisions and updated guidance document for submitting risk management plans: Notice
The following related guidance documents and notices will be published:
- Guidance on collecting and analyzing disaggregated data in clinical trials
- Biologic Drugs (Division 4): Submission Information for Schedule D Drugs – Guidance Document
- New terms and conditions for human and veterinary drugs: Notice.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.